scholarly journals Usability of an At-Home Anterior Nares SARS-CoV-2 RT-PCR Sample Collection Kit: Human Factors Feasibility Study (Preprint)

2021 ◽  
Author(s):  
Laura E Strong ◽  
Irene Middendorf ◽  
Michelle Turner ◽  
David K Edwards V ◽  
Varun Sama ◽  
...  
Keyword(s):  
Health Care ◽  
Human Factors ◽  
Nasal Swab ◽  
Medical Laboratory ◽  
Written Feedback ◽  
Swab Sample ◽  
Sample Collection ◽  
Rt Pcr ◽  
Nasal Swab Sample ◽  
At Home

BACKGROUND Readily available testing for SARS-CoV-2 is necessary to mitigate COVID-19 disease outbreaks. At-home collection kits, in which samples are self-collected without requiring a laboratory or clinic visit and sent to an external laboratory for testing, can provide convenient testing to those with barriers to access. They can prevent unnecessary exposure between patient and clinical staff, increase access for patients with disabilities or remote workers, and decrease burdens on health care resources, such as provider time and personal protective equipment. Exact Sciences developed an at-home collection kit for samples to be tested to detect SARS-CoV-2 that includes an Instructions for Use (IFU) document, which guides people without prior experience on collecting a nasal swab sample. Demonstrating successful sample collection and usability is critical to ensure that these samples meet the same high-quality sample collection standards as samples collected in clinics. OBJECTIVE The aim of this study was to determine the usability of a SARS-CoV-2 at-home nasal swab sample collection kit. METHODS A human factors usability study was conducted with 30 subjects without prior medical, laboratory, or health care training and without COVID-19 sample self-collection experience. Subjects were observed while they followed the IFU for the at-home sample collection portion of the SARS-CoV-2 test in a setting that simulated a home environment. IFU usability was further evaluated by requiring the subjects to complete a survey, answer comprehension questions, provide written feedback, and respond to questions from the observer about problems during use. RESULTS All 30 subjects successfully completed the sample collection process, and all 30 samples were determined by reverse transcription–polymerase chain reaction (RT-PCR) testing to meet quality standards for SARS-CoV-2 testing. The subjects’ written feedback and comments revealed several recommendations to improve the IFU. CONCLUSIONS The study demonstrated the overall usability of an at-home SARS-CoV-2 collection kit. Various feedback mechanisms provided opportunities to improve the wording and graphics for some critical tasks, including placing the label correctly on the tube. A modified IFU was prepared based on study outcomes.

scholarly journals Usability of an At-Home Anterior Nares SARS-CoV-2 RT-PCR Sample Collection Kit: Human Factors Feasibility Study (Preprint)

10.2196/29234 ◽  
2021 ◽  
Author(s):  
Laura E Strong ◽  
Irene Middendorf ◽  
Michelle Turner ◽  
Varun Sama ◽  
David K Edwards V ◽  
...  
Keyword(s):  
Human Factors ◽  
Feasibility Study ◽  
Sample Collection ◽  
Rt Pcr ◽  
At Home

scholarly journals A Prospective Study to Evaluate the Clinical Performance of A Novel MultitargetBased Antigen Test on the Detection of SARS-CoV-2 in Symptomatic PopulationComparison to Nuclear Acid-Based Tests

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Yu W ◽  
Rao E ◽  
Wan DD ◽  
Patterson C ◽  
Wan DD ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Nasal Swab ◽  
Clinical Performance ◽  
Performance Characteristics ◽  
Care Providers ◽  
Swab Sample ◽  
Antigen Test ◽  
Rt Pcr ◽  
Clinical Sensitivity

The study was designed to evaluate the clinical performance characteristics of the First Sign® SARS-CoV-2 Antigen Test, a visual read lateral flow immunoassay (W.H.P.M., Inc.). Individuals presenting at the study sites were evaluated by health care providers for COVID-19 symptoms and sequentially enrolled. The standard of care nasopharyngeal swab sample was first collected for RT-PCR testing. Participant self-collection nasal swab sample was then obtained for the Antigen Test. The clinical performance characteristics of the study device were calculated by comparing participant study device test result recorded at the point of care with the participant matched RT-PCR results provided by qualified CLIA high complexity laboratories. A total of 128 symptomatic adult participants were included in the study, of which 46.8% (60/128) were determined to be RT-PCR positive for SARS-CoV-2. The mean comparator cycle threshold value (Ct) for RT-PCR positive participants included in the study was Ct 25 (range Ct 18-Ct 39). The First Sign® SARS-CoV-2 Antigen Test demonstrated an overall clinical sensitivity of 96.7% (58/60) and a clinical specificity of 98.5% (67/68) when compared with EUA RT-PCR comparator results for the detection of SARS-CoV-2 in symptomatic individuals within 5 days of symptom onset. The clinical sensitivity for samples with RT-PCR Ct<30 was 100% (48/48), 90% (10/12) for samples with RT-PCR Ct ≥ 30, and 98.2% (55/56) for samples with RT-PCR Ct ≤ 34. Study results indicate that during the initial phase of infection, when upper respiratory viral loads and viral shedding levels are typically highest, an observed anterior nasal swab self-collected by the patient and applied to the First Sign® SARS-CoV-2 Antigen Test may be as effective in detecting the presence of SARS-CoV-2 in symptomatic individuals as a EUA RT-PCR assay. Additionally, the ability to obtain a low-cost qualitative result within 15 minutes, combined with the simplicity of the anterior nasal self-sampling procedure, may dramatically increase testing efficiency while significantly reducing risk to health care providers by minimizing or eliminating the need for close contact with the patient.

scholarly journals Self-Collected Samples to Detect SARS-CoV-2: Direct Comparison of Saliva, Tongue Swab, Nasal Swab, Chewed Cotton Pads and Gargle Lavage

2021 ◽  
Vol 10 (24) ◽  
pp. 5751
Author(s):  
Niko Kohmer ◽  
Lisa Eckermann ◽  
Boris Böddinghaus ◽  
Udo Götsch ◽  
Annemarie Berger ◽  
...  
Keyword(s):  
Nasal Swab ◽  
Clinical Symptoms ◽  
Tap Water ◽  
Diagnostic Sensitivity ◽  
Lower Sensitivity ◽  
Limited Data ◽  
Sample Collection ◽  
Rt Pcr ◽  
Nasal Swabs ◽  
Different Types

Testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by RT-PCR is a vital public health tool in the pandemic. Self-collected samples are increasingly used as an alternative to nasopharyngeal swabs. Several studies suggested that they are sufficiently sensitive to be a useful alternative. However, there are limited data directly comparing several different types of self-collected materials to determine which material is preferable. A total of 102 predominantly symptomatic adults with a confirmed SARS-CoV-2 infection self-collected native saliva, a tongue swab, a mid-turbinate nasal swab, saliva obtained by chewing a cotton pad and gargle lavage, within 48 h of initial diagnosis. Sample collection was unsupervised. Both native saliva and gargling with tap water had high diagnostic sensitivity of 92.8% and 89.1%, respectively. Nasal swabs had a sensitivity of 85.1%, which was not significantly inferior to saliva (p = 0.092), but 16.6% of participants reported they had difficult in self-collection of this sample. A tongue swab and saliva obtained by chewing a cotton pad had a significantly lower sensitivity of 74.2% and 70.2%, respectively. Diagnostic sensitivity was not related to the presence of clinical symptoms or to age. When comparing self-collected specimens from different material, saliva, gargle lavage or mid-turbinate nasal swabs may be considered for most symptomatic patients. However, complementary experiments are required to verify that differences in performance observed among the five sampling modes were not attributed to collection impairment.

scholarly journals Nasal Swab Performance by Collection Timing, Procedure, and Method of Transport for Patients with SARS-CoV-2

2021 ◽  
Author(s):  
Cody Callahan ◽  
Rose A. Lee ◽  
Ghee Rye Lee ◽  
Kate Zulauf ◽  
James E. Kirby ◽  
...  
Keyword(s):  
Large Scale ◽  
Nasal Swab ◽  
Limit Of Detection ◽  
Diagnostic Testing ◽  
Attractive Alternative ◽  
Sample Collection ◽  
Rt Pcr ◽  
Viral Loads ◽  
High Concordance

The urgent need for large-scale diagnostic testing for SARS-CoV-2 has prompted interest in sample-collection methods of sufficient sensitivity to replace nasopharynx (NP) sampling. Nasal-swab samples are an attractive alternative; however, previous studies have disagreed over how nasal sampling performs relative to NP sampling. Here, we compared nasal vs. NP specimens collected by healthcare workers in a cohort of individuals clinically suspected of COVID-19 as well as SARS-CoV-2 RT-PCR positive outpatients undergoing follow-up. We compared subjects being seen for initial evaluation vs. follow-up, two different nasal-swab collection protocols, and three different transport conditions, including traditional viral transport media (VTM) and dry swabs, on 307 total study participants. We compared categorical results and viral loads to those from standard NP swabs collected at the same time from the same patients. All testing was performed by RT-PCR on the Abbott SARS-CoV-2 RealTime EUA (limit of detection [LoD], 100 copies viral genomic RNA/mL transport medium). We found low concordance overall, with Cohen’s kappa of 0.49, with high concordance only for subjects with very high viral loads. We found medium concordance for testing at initial presentation (κ=0.68), and very low concordance for followup testing (κ=0.27). Finally, we show that previous reports of high concordance may have resulted from measurement using assays with sensitivity ≥1,000 copies/mL. These findings suggest nasal-swab testing be used for situations in which viral load is expected to be high, as we demonstrate that nasal-swab testing is likely to miss patients with low viral loads.

Effective optimization of SARS-CoV-2 laboratory testing variables in an era of supply chain constraints

2020 ◽  
Vol 15 (15) ◽  
pp. 1483-1487
Author(s):  
Nikhil S Sahajpal ◽  
Ashis K Mondal ◽  
Allan Njau ◽  
Sudha Ananth ◽  
Kimya Jones ◽  
...  
Keyword(s):  
Supply Chain ◽  
Rna Extraction ◽  
Nasopharyngeal Swab ◽  
Sample Collection ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Short Supply ◽  
Viral Transport ◽  
3D Printed ◽  
Bridging Studies

RT-PCR-based assays for the detection of SARS-CoV-2 have played an essential role in the current COVID-19 pandemic. However, the sample collection and test reagents are in short supply, primarily due to supply chain issues. Thus, to eliminate testing constraints, we have optimized three key process variables: RNA extraction and RT-PCR reactions, different sample types and media to facilitate SARS-CoV-2 testing. By performing various validation and bridging studies, we have shown that various sample types such as nasopharyngeal swab, bronchioalveolar lavage and saliva, collected using conventional nasopharyngeal swabs, ESwab or 3D-printed swabs and, preserved in viral transport media, universal transport media, 0.9% sodium chloride or Amies media are compatible with RT-PCR assay for COVID-19. Besides, the reduction of PCR reagents by up to fourfold also produces reliable results.

scholarly journals Caring for One’s Wife With Dementia—at Home: Older Husbands’ Experiences With Managing Challenges of Everyday Life

SAGE Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. 215824401983445
Author(s):  
Linda Rykkje ◽  
Oscar Tranvåg
Keyword(s):  
Health Care ◽  
Health Care Services ◽  
Qualitative Interviews ◽  
Care Services ◽  
People With Dementia ◽  
Memory Clinics ◽  
Male Caregivers ◽  
Caregiving Roles ◽  
Caregiver Role ◽  
At Home

More than 80,000 Norwegians live with dementia. Most caregivers for people with dementia are spouses, and women outnumber men. Due to an aging population, and women’s higher risk of dementia as well as men’s increased life expectancy, the number of male caregivers will rise. There are some differences in the caregiving roles of men and women. Research suggest that males report lower burden and depression than female caregivers, but some men struggle to adjust to the caregiver role, and men are less likely to access health care services. The aim of this study is to explore the experiences of husbands engaged in caregiving for their home-dwelling spouse with dementia. This knowledge will add to the growing body of research about men in the context of dementia care and may raise gender awareness. The method is qualitative interviews with hermeneutical interpretation. The participants are five husbands recruited from two Hospital Memory Clinics in Norway. The results portray how the husbands managed their everyday challenges, and how they adapted to changes, experiences of loss and bereavement, and how they redefined personal freedom and expanded their responsibilities. Acknowledging the rewards of caregiving, the husbands found their life meaningful and they were thriving in their caregiving role. Health care personnel should recognize and respect the challenging life situation caregiving husbands may experience, calling for personnel to learn from, care for, and collaborate with them, enabling the couple to live a meaningful life together at home as long as possible.

scholarly journals Older people living at home: experiences of healthy ageing

2021 ◽  
Vol 22 ◽  
Author(s):  
Astrid Fjell ◽  
Kristin Ådnøy Eriksen ◽  
Monica Hermann ◽  
Anne-Marie Boström ◽  
Seiger Berit Cronfalk
Keyword(s):  
Health Care ◽  
Older People ◽  
Older Persons ◽  
Health Care Services ◽  
Healthy Ageing ◽  
Group Discussions ◽  
Care Services ◽  
Manifest Content ◽  
Professional Perspective ◽  
At Home

Abstract Aim: The purpose of this study was to investigate how old persons perceived their life to be, how they viewed the ageing process and their need of health care and societal support. Background: The purpose of WHO’s Healthy Ageing strategy and development of age-friendly environments is to support physiological and psychosocial changes in old persons by facilitating basic needs. Interventions to operationalize these needs in older people living at home are often developed from a professional perspective and to a small extent involves the perceptions, experience and expectations of the older persons. Method: This qualitative study has an explorative design using focus group discussions to collect data. In all, 34 persons between 69 and 93 years of age participated in seven group discussions. The interviews were analyzed using inductive manifest content analysis. Findings: The main results suggest that most old persons enjoyed life and wished it to continue for as long as possible. Important was to sustain networks and to feel useful. Unexpected changes were described as threats and the need to use health care services was associated with illness and being dependent. The result is presented in three categories with sub-categories: ‘Embracing life’, ‘Dealing with challenges’ and ‘Considering the future’.

scholarly journals Household transmission and incidence of positive SARS-CoV-2 RT-PCR in symptomatic healthcare workers, clinical course and outcome: a French hospital experience

2020 ◽  
pp. oemed-2020-106866
Author(s):  
Evguenia Krastinova ◽  
Valérie Garrait ◽  
Marie-Thérèse Lecam ◽  
André Coste ◽  
Emmanuelle Varon ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Current Smoker ◽  
Infection Rates ◽  
Rt Pcr ◽  
Living Situation ◽  
Household Transmission ◽  
Occupational Profile ◽  
Household Members ◽  
French Hospital ◽  
At Home

ObjectivesAlthough healthcare workers (HCWs) have been particularly affected by SARS-CoV-2, detailed data remain scarce. In this study, we investigated infection rates, clinical characteristics, occupational exposure and household transmission among all symptomatic HCWs screened by SARS-CoV-2 RT-PCR between 17 March (French lockdown) and 20 April.MethodsSARS-CoV-2 RT-PCR was proposed to symptomatic (new cough or dyspnoea) HCWs at Creteil Hospital in one of the Parisian suburbs most severely affected by COVID-19. Data on occupational profile, living situation and household, together with self–isolation and mask use at home were collected, as well as the number of cases in the household.ResultsThe incidence rate of symptomatic SARS-CoV-2 was estimated to be 5% (110/2188). A total of 110 (35%) of the 314 HCWs tested positive and 9 (8%) were hospitalised. On multivariate analysis, factors independently associated with positive RT-PCR were occupational profile with direct patient facing (OR 3.1, 95% CI 1.1 to 8.8), p<0.03), and presence of anosmia (OR 5.7, 95% CI 3.1 to 10.6), p<0.0001). Being a current smoker was associated with negative RT-PCR (OR 0.3, 95% CI 0.1 to 0.7), p=0.005). Transmission from HCWs to household members was reported in 9 (14%) cases, and 2 deaths occurred. Overall, self-isolation was possible in 52% of cases, but only 31% of HCWs were able to wear a mask at home.ConclusionThis is the first study to report infection rates among HCWs during the peak of the SARS-CoV-2 epidemic in France and the lockdown period, highlighting the risk related to occupational profile and household transmission.

scholarly journals Diagnosis of SARS-Cov-2 Infection by RT-PCR Using Specimens Other Than Naso- and Oropharyngeal Swabs: A Systematic Review and Meta-Analysis

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 363
Author(s):  
Vânia M. Moreira ◽  
Paulo Mascarenhas ◽  
Vanessa Machado ◽  
João Botelho ◽  
José João Mendes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Performance ◽  
Point Of Care ◽  
Meta Analysis ◽  
High Sensitivity ◽  
Nasopharyngeal Swab ◽  
Sample Collection ◽  
Rt Pcr ◽  
Oropharyngeal Swab ◽  
Nucleic Acid Assays

The rapid and accurate testing of SARS-CoV-2 infection is still crucial to mitigate, and eventually halt, the spread of this disease. Currently, nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) are the recommended standard sampling techniques, yet, these have some limitations such as the complexity of collection. Hence, several other types of specimens that are easier to obtain are being tested as alternatives to nasal/throat swabs in nucleic acid assays for SARS-CoV-2 detection. This study aims to critically appraise and compare the clinical performance of RT-PCR tests using oral saliva, deep-throat saliva/posterior oropharyngeal saliva (DTS/POS), sputum, urine, feces, and tears/conjunctival swab (CS) against standard specimens (NPS, OPS, or a combination of both). In this systematic review and meta-analysis, five databases (PubMed, Scopus, Web of Science, ClinicalTrial.gov and NIPH Clinical Trial) were searched up to the 30th of December, 2020. Case-control and cohort studies on the detection of SARS-CoV-2 were included. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2). We identified 1560 entries, 33 of which (1.1%) met all required criteria and were included for the quantitative data analysis. Saliva presented the higher accuracy, 92.1% (95% CI: 70.0–98.3), with an estimated sensitivity of 83.9% (95% CI: 77.4–88.8) and specificity of 96.4% (95% CI: 89.5–98.8). DTS/POS samples had an overall accuracy of 79.7% (95% CI: 43.3–95.3), with an estimated sensitivity of 90.1% (95% CI: 83.3–96.9) and specificity of 63.1% (95% CI: 36.8–89.3). The remaining index specimens could not be adequately assessed given the lack of studies available. Our meta-analysis shows that saliva samples from the oral region provide a high sensitivity and specificity; therefore, these appear to be the best candidates for alternative specimens to NPS/OPS in SARS-CoV-2 detection, with suitable protocols for swab-free sample collection to be determined and validated in the future. The distinction between oral and extra-oral salivary samples will be crucial, since DTS/POS samples may induce a higher rate of false positives. Urine, feces, tears/CS and sputum seem unreliable for diagnosis. Saliva testing may increase testing capacity, ultimately promoting the implementation of truly deployable COVID-19 tests, which could either work at the point-of-care (e.g. hospitals, clinics) or at outbreak control spots (e.g., schools, airports, and nursing homes).

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